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PATHFAST®hs-cTnI-II

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231974
510(k) Type
Traditional
Applicant
PHC Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
3/20/2024
Days to Decision
261 days
Submission Type
Summary

PATHFAST®hs-cTnI-II

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231974
510(k) Type
Traditional
Applicant
PHC Corporation
Country
Japan
FDA Decision
Substantially Equivalent
Decision Date
3/20/2024
Days to Decision
261 days
Submission Type
Summary